Satisfaction Survey of Patients Over Hypnoanalgesia or Hypnosedation at a Digestive Endoscopy or Surgery

Endoscopy Clinical Trial

— SEDuCE  

Official title:

Satisfaction Survey of Patients Over Hypnoanalgesia or Hypnosedation at a Digestive Endoscopy or Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834091
• Other study ID #: SEDuCE
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: September 4, 2017
• Start date: January 22, 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of hypnosedation in the context of anesthesia is validated. This is a technique that combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with local anesthesia surgical site. It can favorably replace general anesthesia if surgery or endoscopy allows but doctors will always need local anesthesia surgical site where surgery The hospital Paris Saint joseph introduced gradually this technique from first in 2007 to the operating room and in the various services of conventional and ambulatory hospitalizations.

The goal of the investigators is to evaluate these parameters on a prospective cohort of patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or surgery.

Description:

The use of medical hypnosis has been developing for about fifteen years in several health facilities.

The Hospital Group Paris Saint-Joseph has progressively introduced first this technique from 2007 to the operating room and in the various services of conventional and ambulatory hospitalizations.

The French Society of Anesthesia and Intensive Care (SFAR) recognizes the hypnosedation as sedation technique that can be used in acute pain and anesthesia (operating theater, emergency, painful treatments ...).

There are currently many quality scientific papers published in international journals in particular by the team of Pr. M. E. Faymonville Liege, who explained the mechanisms and consequences of hypnosedation.

The use of hypnosedation in the context of anesthesia is validated. This is a technique that combines the hypnosis procedure as intravenous sedation. For surgery, it is associated with local anesthesia surgical site. It can favorably replace general anesthesia if surgery or endoscopy allows but doctors will always need local anesthesia surgical site where surgery. It can also complement a regional anesthesia to increase patient comfort (less stress, anxiety and pain) .If necessary, the conversion of general anesthesia hypnosedation is always possible during surgery or gastrointestinal endoscopy.

In the Paris Saint joseph Hospital facility, several anesthesiologists and nurse anesthetists are trained in medical hypnosis. Now, a common practice in surgery hypnosedation (inguinal hernia, thyroid and para-thyroid surgery) and endoscopy (colonoscopy, gastroesophageal gastroduodenal endoscopy) .On a period of 3 years, 414 acts were carried out under hypnosedation. When digestive endoscopy adding sedation is not systematic and, if the patient is comfortable enough without conscious sedation, only hypnoanalgesia is used (use of hypnosis in the prevention or relief of acute pain or chronic).

This technique is part of the panel modes of analgesia and anesthesia can be offered to patients. However, little is known about patient satisfaction and their experiences during the procedure under hypnosedation.

The objective is to evaluate these parameters on a prospective cohort of patients supported by hypnosedation in Paris Saint Joseph hospital for an endoscopy or surgery.

This evaluation is part of the evaluation of professional practices (EPP) recommended by the HAS (french High Authority of Health) and the ARS (Regional Health Agency).

Main objective / secondary

Primary objective :

Measure satisfaction of patients resorted to hypnosedation or hypnoanalgesia during an endoscopy or surgery

Secondary objective:

Measure the doses of drugs used for conscious sedation

Methodology :

• DESIGN: Prospective cohort single-center, non-interventional kind EPP on the satisfaction of patients who underwent hypnosedation for surgery or endoscopy

• Duration of the study: 8 months (November 2015-June 2016): the estimated number of 80 patients

• Acquisition of data:

• Age, weight, height, gender, ASA (Physical status score) score

• Type of surgery or endoscopy

• Previous history of surgery or endoscopy

• Names and doses of treatments

• Conversion to general anesthesia yes / no

• Length of management in operating room

• Adverse events during surgery and in recovery

• Evaluation using a numerical scale from 0 to 10:

• Patient anxiety during the pre- and per-interventional

• The per-Interventional Pain, Interventional immediate post-and before the release of the SSPI (The post-interventional surveillance room)

• The feeling of active participation in the intervention

• The quality of the relationship with the hypnotist during surgery

• Overall satisfaction during surgery

• Acceptance or not the patient to repeat surgery or examination under the same terms

• Acceptance or not to recommend the patient to the relatives hypnosedation

• Case open for any comments or suggestions obviousness

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: November 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who chose surgery or endoscopy under hypnosedation

• Selected in consultation surgery or gastroenterology for a realization of the act under hypnosedation.

• Having a pre-hypnosedation anesthesia consultation by an anesthesiologist trained in hypnosis with validation of eligibility for hypnosedation.

• No opposition to participate in the study

Exclusion Criteria:

• Absence affiliate to a social security scheme

• Patients not eligible for hypnosedation:

• No specific consultation pre-anesthesia hypnosedation

• Poor understanding of the French language

• Major Hearing problems

• Severe cognitive or psychiatric disorders

• Insufficient reasoning or refusal with respect to the use of hypnosedation

• Administration of anxiolytic premedication

Related Conditions & MeSH terms

• Endoscopy
• Surgery, Digestive System

Intervention

Procedure:
• Hypnoanalgesia

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Patient satisfaction	Patient satisfaction rated on a scale from 0 (dissatisfied) to 10 (extremely satisfied).; An average value: <5: low satisfaction; From 5 to 7.4: Average satisfaction •> 7.5: Important satisfaction	Day 1 After Hypnoanalgesia or Hypnosedation
Secondary	Pain Assessment	Pain: An average value: <3: low or no pain; From 3 to 5.9: moderate pain •> 5.9: strong pain	Day 1 within the first hour after Hypnoanalgesia or Hypnosedation
Secondary	Anxiety assessment	An average value: <3: low or absent anxiety; From 3 to 5.9: moderate anxiety •> 5.9: high anxiety	Day 1 within the first hour after Hypnoanalgesia or Hypnosedation